- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02246530
Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- UAB Highlands
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- subjects between ages 19 to 75, both male and female
- radiologic imaging which can include either magnetic resonance imaging (MRI) or ultrasound (US) consistent with partial thickness rotator cuff tears of any degree except for full thickness tears
- Failed a trial of physical therapy of at least 4 weeks
Exclusion Criteria:
- Full thickness tears (well documented need for surgical correction)
- sensory or neurologic complaint affecting the shoulder of interest
- Coagulation disorder, platelet disorder
- Pregnancy: Pregnancy test will be performed on women of childbearing age prior to their participation in the interventional portion of the study
- Any major systemic illness such as ongoing infection or any condition that requires strict anti-platelet or anticoagulation therapy
- Prior surgery to either cervical spine or shoulder
- Active military
- Injury part of worker compensation claim
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PRP injection into PTRCT
Treatment - PRP injection
|
Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury. PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.
Other Names:
|
Active Comparator: Subacromial steroid bursal injection
Current standard of care for treatment of resistant partial thickness rotator cuff tears
|
Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic Ultrasound
Time Frame: 6 months post procedure
|
Comparing baseline diagnostic ultrasound for structural changes. An initial diagnostic ultrasound image was obtained to demonstrate a tear of the supraspinatus tendon, a key tendon of the rotator cuff. Once a tear of this tendon was confirmed, patient were delegated to one of the study arms and proceeded to the injection phase of the study. Two subject's data (within the PRP group) is incomplete as these subjects were lost to follow up and do not have completed 6 month follow up ultrasound imaging to review. |
6 months post procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder Pain and Disability Index
Time Frame: Week 3 post procedure SPADI Scores for the control and treatment groups.
|
Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%. In the PRP (platelet rich plasma injection) group we had 5 participants completed the study. 2 participants in the control (corticosteroid injection) group completed the study. |
Week 3 post procedure SPADI Scores for the control and treatment groups.
|
Shoulder Pain and Disability Index
Time Frame: Week 6 post procedure SPADI Scores for the treatment and control groups.
|
Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%. In the PRP (platelet rich plasma injection) group we had 5 participants completed the study. 2 participants in the control (corticosteroid injection) group completed the study. |
Week 6 post procedure SPADI Scores for the treatment and control groups.
|
Shoulder Pain and Disability Index
Time Frame: 6 months post procedure SPADI scores for the treatment and control groups.
|
Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%. In the PRP (platelet rich plasma injection) group we had 5 participants completed the study. 2 participants in the control (corticosteroid injection) group completed the study. |
6 months post procedure SPADI scores for the treatment and control groups.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Breanna Willeford, DO, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F131231006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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